FDA.reportPublic FDA data

Elite Orthopaedics

Primary DI
00816591013370
Brand
Elite Orthopaedics
Company
Elite Orthopaedics, Inc.
Model
34128
Catalog number
34128
Device description
Arm Sling, Economy, X-Large
Published
2023-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ILISling, Arm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILISling, ArmPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816591013370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816591013370008165910133708165910133700816591013370

GMDN Terms#

Term, Definition table
TermDefinition
Arm immobilizerA non-rigid device, usually made of a fabric, used to temporarily render the arm immovable, typically at the shoulder and elbow, to support healing of an injury or a surgical wound. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
803168228
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816591010690Elite Orthopaedics30061-R30061-R2023-08-17
00816591010706Elite Orthopaedics30061-L30061-L2023-08-17
00816591010713Elite Orthopaedics30062-R30062-R2023-08-17
00816591010720Elite Orthopaedics30062-L30062-L2023-08-17
00816591010737Elite Orthopaedics30063-R30063-R2023-08-17
00816591010744Elite Orthopaedics30063-L30063-L2023-08-17
00816591010751Elite Orthopaedics30064-R30064-R2023-08-17
00816591010768Elite Orthopaedics30064-L30064-L2023-08-17
00816591010775Elite Orthopaedics30065-R30065-R2023-08-17
00816591010782Elite Orthopaedics30065-L30065-L2023-08-17
00816591010799Elite Orthopaedics31061-R31061-R2023-08-18
00816591010805Elite Orthopaedics31062-R31062-R2023-08-18
00816591010812Elite Orthopaedics31063-R31063-R2023-08-18
00816591010829Elite Orthopaedics31064-R31064-R2023-08-18
00816591010836Elite Orthopaedics31065-R31065-R2023-08-18
00816591010843Elite Orthopaedics31061-L31061-L2023-08-18
00816591010850Elite Orthopaedics31062-L31062-L2023-08-18
00816591010867Elite Orthopaedics31063-L31063-L2023-08-18
00816591010874Elite Orthopaedics31064-L31064-L2023-08-18
00816591010881Elite Orthopaedics31065-L31065-L2023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756880282DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880299DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880312DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880329DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880336DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880343DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880930DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880947DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880954DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880961DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
06974500613616Arm SlingGCMEDICA ENTERPRISE LTD.(WUXI)ILI2025-12-12
06974500613623Arm SlingGCMEDICA ENTERPRISE LTD.(WUXI)ILI2025-12-12
16974500613613Arm SlingGCMEDICA ENTERPRISE LTD.(WUXI)ILI2025-12-12
16974500613620Arm SlingGCMEDICA ENTERPRISE LTD.(WUXI)ILI2025-12-12
00810113683041Kangaroo 3960Manamed, Inc.ILI2025-10-17
00810113683027Shoulder Brace with Airplane KitManamed, Inc.ILI2025-09-19
00810113683034Shoulder Brace with Airplane Kit LOGOManamed, Inc.ILI2025-09-19
00190446660354PROCAREDJO, LLCILI2025-07-14
00749756397841DeRoyalDEROYAL INDUSTRIES, INC.ILI2025-02-27
50749756397846DeRoyalDEROYAL INDUSTRIES, INC.ILI2025-02-27
00749756397285DeRoyalDEROYAL INDUSTRIES, INC.ILI2025-02-13
00840314811097UNIV ARM SLING W/FOAM STRAP ADULTHausmann Enterprises, LLCILI2025-01-01
M68932600100CravatSafeguard US Operating, LLCILI2024-10-09
00810113576947CoreTechVIVE HEALTH LLCILI2024-06-10
10810113576944CoreTechVIVE HEALTH LLCILI2024-06-10
00057475611026BIOS LivingThermor LtdILI2024-05-23
10057475611023BIOS LivingThermor LtdILI2024-05-23
00888912014366DONJOYDJO, LLCILI2024-02-27
07798094540061WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540078WELLBRACEPANTYMED S.A.ILI2024-01-05